Clinical Research Coordinator

Clinical Research Coordinator

Monday-Friday 8am-5pm

Fountain Valley, CA 92708

Overview

The Clinical Research Coordinator works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Responsibilities

• Screen prospective patients for protocol eligibility and guide them through non-medical study education and the informed consent process
• Coordinate scheduling for all research-related visits and procedures
• Partner with investigators and clinical staff to document patient status changes, adverse events, concomitant medications, and protocol/drug-response data on CRFs
• Maintain source documentation that accurately supports all study activity
• Own data entry, collection, and reporting timelines, including prompt turnaround on sponsor queries
• Support monitoring visits and internal/external audits
• Track and report study metrics (protocol status, enrollment, workload, etc.) and present updates at team meetings
• Flag data quality or conduct concerns to leadership promptly
• Coordinate with regulatory staff or the IRB directly on AE/SAE reporting, deviations, and safety notifications per federal and local requirements
• May assist with research billing reconciliation
• Ensure ongoing compliance with FDA, IRB, and GCP standards
• Uphold HIPAA and patient confidentiality requirements at all times
• May train or mentor other research staff
• May contribute to broader initiatives like SOP development or centralized audits
• Develop and execute strategies to boost enrollment and streamline study operations

Qualifications

• HS Diploma or GED, BA/BS Degree – Preferred.
• ACRP/SoCRA (or equivalent) certification preferred.
• 1 year minimum of clinical research coordination experience, required
• Previous Oncology/Hematology experience preferred.